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A kind of pharmaceutical preparation and its use

A unit preparation and mixture technology, which is applied in the field of biomedicine, can solve the problems of not containing acid-base regulators, easy to cause oxidative degradation, complex preparation process, etc., and achieve excellent light resistance, easy industrial production, and simple preparation.

Active Publication Date: 2022-03-01
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN102100671A discloses a kind of esomeprazole magnesium enteric-coated pellet and its preparation method. Enteric-coated pellets are prepared layer by layer, but the isolation layer of the pellets does not contain acid-base regulators. When the drug migrates to the isolation layer from the inside to the outside as the storage time prolongs, contact with the acidic enteric material may leading to the breakdown of the drug
Chinese patent CN102670521A discloses a kind of esomeprazole magnesium enteric-coated pellets and its preparation method. The enteric-coated pellets use acid-base regulators in the drug-containing layer and the isolation layer to adjust the pH value and enhance the esomeprazole magnesium enteric-coated pellets. The stability of prazole magnesium, but no antioxidant is added in the drug layer, the drug is easy to cause oxidative degradation in the process of preparation and storage, and the preparation process is complicated

Method used

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  • A kind of pharmaceutical preparation and its use
  • A kind of pharmaceutical preparation and its use
  • A kind of pharmaceutical preparation and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A kind of preparation method of esomeprazole magnesium sodium bicarbonate capsule, the preparation raw material of its unit preparation comprises: esomeprazole magnesium: 22.3mg; Sodium bicarbonate: 1100mg; Disintegrant: 10mg; Lubricant: 4mg.

[0029] The particle size distribution of the sodium bicarbonate is D90 of 50 μm.

[0030] The particle size distribution of the esomeprazole magnesium is that the D90 is 5 μm.

[0031] Include the following steps:

[0032] (1) get mixture A after mixing the 70% sodium bicarbonate of formula consumption and the full amount of esomeprazole magnesium of formula consumption;

[0033] (2) After mixing the disintegrant, lubricant and remaining sodium bicarbonate of formula dosage, add purified water, the weight of adding water is 1 times of esomeprazole magnesium weight, mix completely, obtain mixture B;

[0034] (3) The obtained mixture A and the mixture B are mixed completely, freeze-dried to obtain a drug powder, and the obtained...

Embodiment 2

[0042] A kind of preparation method of esomeprazole magnesium sodium bicarbonate capsule, the preparation raw material of its unit preparation comprises: esomeprazole magnesium: 22.3mg; Sodium bicarbonate: 1100mg; Disintegrant: 35mg; Lubricant: 10mg.

[0043] The particle size distribution of the sodium bicarbonate has a D90 of 500 μm.

[0044] The particle size distribution of the esomeprazole magnesium is that the D90 is 40 μm.

[0045] Include the following steps

[0046] (1) get mixture A after mixing the 80% sodium bicarbonate of formula consumption and the full amount of esomeprazole magnesium of formula consumption;

[0047] (2) After mixing the disintegrating agent, lubricant and remaining sodium bicarbonate of formula dosage, add purified water, the weight of adding water is 1 times of esomeprazole magnesium weight, mix well, obtain mixture B;

[0048] (3) The obtained mixture A and the mixture B are mixed, freeze-dried to obtain a drug powder, and the obtained dru...

Embodiment 3

[0056] A kind of preparation method of esomeprazole magnesium sodium bicarbonate capsule, the preparation raw material of its unit preparation comprises: esomeprazole magnesium: 22.3mg; Sodium bicarbonate: 1100mg, disintegrant: 25mg, lubricant: 7mg.

[0057] The particle size distribution of the sodium bicarbonate is D90 of 230 μm.

[0058] The particle size distribution of the esomeprazole magnesium is that the D90 is 15 μm.

[0059] Include the following steps

[0060] (1) get mixture A after mixing the 75% sodium bicarbonate of formula consumption and the full amount of esomeprazole magnesium of formula consumption;

[0061] (2) After mixing the disintegrating agent, lubricant and remaining sodium bicarbonate of formula dosage, add purified water, the weight of adding water is 1 times of esomeprazole magnesium weight, mix well, obtain mixture B;

[0062] (3) The obtained mixture A and the mixture B are mixed, freeze-dried to obtain a drug powder, and the obtained drug po...

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Abstract

The invention relates to the technical field of biomedicine, in particular to a pharmaceutical preparation, the raw materials of which are: esomeprazole magnesium and sodium bicarbonate; wherein the weight ratio of esomeprazole magnesium and sodium bicarbonate is 22.3:1100; Among them, the particle size of esomeprazole magnesium is D90 5-40 μm, and the particle size of sodium bicarbonate is D90 50 μm-500 μm. The applicant has found through many creative studies that the particle diameter of esomeprazole magnesium and sodium bicarbonate, as well as the composition of raw and auxiliary materials, etc., have a direct impact on the quality of capsules. Research shows that: capsules of the present invention have Better dissolution, uniformity and stability.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a pharmaceutical preparation and its application, more specifically to a capsule preparation and application of esomeprazole magnesium sodium bicarbonate as a raw material. Background technique [0002] Esomeprazole is the levorotatory isomer of omeprazole and is the first single isomer proton pump inhibitor (PPI) developed by AstraZeneca. Esomeprazole magnesium trihydrate, molecular formula C 34 h 36 N 6 o 6 S 2 Mg·3H 2 O, the chemical name is 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-benzimidazole Magnesium salt trihydrate. As a new generation of proton pump inhibitors with only one isomer, esomeprazole has a strong acid-suppressing effect. It is an active substance, which can specifically inhibit the proton pump in gastric parietal cells to reduce the secretion of gastric acid, and can inhibit the basic gastric acid secretion. [0003]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/4439A61K33/00A61K47/36A61K47/38A61K47/46A61P1/04A61P31/04
CPCA61K9/4866A61K31/4439A61K33/00A61P1/04A61P31/04A61K2300/00
Inventor 董伟苏成伟杨万军宋丽影
Owner 长春海悦药业股份有限公司